Quality Systems Specialist I

Job Description:
The Quality Systems Specialist roles are responsible for providing support for all Quality policies, systems, programs, and initiatives.
PRIMARY DUTIES AND RESPONSIBILITIES
Quality Systems Specialist: Level 1

• Participate in all Quality Management System (QMS) activities including document change management, records management, training/competency, non-conforming material reports (NCMRs), and Corrective and Preventive Actions (CAPAs)
• Support post market surveillance including recall/modification management, preventative maintenance intervals, equipment incidents, and complaints
• Explain scientific and technical ideas by authoring clear and concise QMS documents, equipment handling procedures, forms, cleaning policies, medical equipment management plans (MEMPs), safety alerts, training materials, user guides, internal communications, and customer letters through the use of structured writing and content management
• Participate in the creation and maintenance of Management Review materials including the oversight and reporting out of Quality Indicators (QIs)/metrics
• Provide Quality support and expertise to the field offices by responding to all communications received through the Quality email service or phone support lines
• Assist in internal and external ISO 13485 audits of QMS
• Monitor governmental and associated industry organizations' standards, guidelines, and policies (ISO, FDA, TJC, DNV, NFPA, CMS, AAMI, CDC, AABB, etc.)
• Participate in tasks associated with Infection Control, Bloodborne Pathogen laws, an
• d equipment cleaning validations

REQUIRED EXPERIENCE

• Quality Systems Specialist: Level 1
  • Bachelor's degree in life sciences, engineering, or technical communications strongly preferred
  • 0 - 3 years Quality or other applicable experience

REQUIRED SKILLS & ABILITIES

• Proficient computer skills in MS Office Suite and in an electronic ERP system
• Ability to sit, stand, lift, bend and stoop numerous times throughout the day
• Flexibility in work schedule in order to meet department needs; may require up to 10% travel
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Management System, Quality Policy, and all other documented quality processes and procedures
• For those individuals that supervise others, the following statements are applicable:
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality Management System compliance and adherence to the Quality Policy
  • Establishes and promotes a work environment that supports the Quality Management System and Quality Policy

These job descriptions in no way state or imply that these are the only duties to be performed by the employee in one of these positions. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department.
It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti's investigation of such reports. Affirmative Action Policy Statements
You may be required to obtain certain vaccinations, or provide proof of current vaccination status, based on customer and/or company requirements. If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic. Please note, this includes the COVID-19 vaccination.
Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, Employee Stock Purchase Program (ESPP) and wellness programs.
Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law.
If you require assistance with your application, please contact recruiting@agilitihealth.com.
Primary Job Location:
Ellis KS Branch
Additional Locations (if applicable):
Hays KS Branch
Job Title:
Quality Systems Specialist I
Company:
Agiliti
Location City:
Ellis
Location State:
Kansas